Vitamin B Complex as Adjunct Therapy for Moderate-to-Severe Dry Eye Disease

Dry eye disease is a common multifactorial condition of the ocular surface characterized by tear film instability, hyperosmolarity, and inflammation. B-complex vitamins (especially vitamins B1, B6, and B12) act as coenzymes in neuronal and cellular metabolism and may support ocular surface health and reduce neuropathic ocular pain.

This prospective, randomized controlled trial was conducted at the College of Applied Medical Sciences Clinics, King Saud University, between January and June 2023. Eligible participants were adults aged 18-60 years with moderate-to-severe dry eye disease (tear break-up time ≤ 10 seconds and Schirmer test \< 10 mm/5 min). Exclusion criteria included corneal disease, previous refractive surgery, contact lens wear, glaucoma, diabetic retinopathy, optic neuropathy, uveitis, current use of corticosteroids, immunomodulatory agents, antihistamines, or any ongoing dry eye treatment.

Participants were randomly assigned to one of two groups:

• Group A (Control): Preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily for two months.
• Group B (Treatment): The same artificial tears plus one daily oral tablet of vitamin B complex (Neurorubine®: thiamine 200 mg, pyridoxine 50 mg, cyanocobalamin 1 mg) for two months.

Clinical assessments were performed at baseline and after two months. Outcome measures included:

• Ocular Surface Disease Index (OSDI) score
• Tear meniscus height (TMH)
• Non-invasive keratograph tear break-up time (NIK-TBUT)
• Fluorescein tear break-up time (fTBUT)
• Schirmer test (without anesthesia)
• Patient treatment satisfaction questionnaire

A total of 56 participants (28 per group) completed the study. Both groups showed significant improvement in OSDI scores. The combined therapy group demonstrated superior improvements in tear meniscus height and non-invasive tear break-up time compared with artificial tears alone.

Participants received preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily for two months.

Drug: Carboxymethylcellulose Sodium 0.5% Eye Drops

Participants received preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily plus one daily oral tablet of vitamin B complex (Neurorubine®) for two months.

Drug: Carboxymethylcellulose Sodium 0.5% Eye Drops · Dietary Supplement: Vitamin B Complex

Preservative-free artificial tears, one drop in each eye four times daily for two months.

Oral tablet containing thiamine 200 mg, pyridoxine 50 mg, and cyanocobalamin 1 mg, taken once daily for two months.

Plazo: Baseline and 2 months

The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used to assess dry eye symptoms and their impact on vision-related functioning. The total score ranges from 0 to 100, with 0 representing no symptoms and 100 representing the most severe symptoms. Higher scores indicate greater dry eye disease severity and worse outcomes.

The conventional OSDI severity categories are:

• 0-12: Normal
• 13-22: Mild
• 23-32: Moderate
• 33-100: Severe

Plazo: Baseline and 2 months

Change in Tear Meniscus Height (TMH), measured in millimeters (mm), from baseline to the specified follow-up assessment. TMH is an objective indicator of tear volume. Higher TMH values generally indicate greater tear volume and are considered a favorable outcome in patients with aqueous-deficient dry eye disease. The measurement is recorded as a continuous variable. No fixed minimum or maximum values are specified for this outcome measure.

Higher values Generally indicate greater tear volume and a better outcome Outcome calculation Follow-up TMH minus baseline TMH

Plazo: Baseline and 2 months

Non-Invasive Keratograph Tear Break-Up Time (NIK-TBUT), measured in seconds (s), from baseline to the specified follow-up assessment. NIK-TBUT is an objective measure of tear film stability, determined using a non-invasive keratograph. The measurement is recorded as a continuous variable. Higher values indicate longer tear film stability and generally represent a better clinical outcome. No fixed minimum or maximum values are specified for this measurement.

Plazo: Baseline and 2 months

Fluorescein Tear Break-Up Time (fTBUT), measured in seconds (s), from baseline to the specified follow-up assessment. fTBUT is an objective clinical measure of tear film stability, determined by measuring the time elapsed between fluorescein instillation and the appearance of the first break in the tear film. The measurement is recorded as a continuous variable. Higher values indicate greater tear film stability and generally represent a better clinical outcome. No fixed minimum or maximum values are specified for this measurement.

Plazo: Baseline and 2 months

Schirmer Test, measured in millimeters (mm) of wetting of the standardized filter paper strip over 5 minutes, from baseline to the specified follow-up assessment. The Schirmer test is an objective measure of aqueous tear production. The measurement is recorded as a continuous variable, with values typically ranging from 0 to 35 mm over 5 minutes, depending on the test strip and measurement protocol. Higher values indicate greater tear production and generally represent a better clinical outcome in patients with aqueous-deficient dry eye disease.

Plazo: 2 months

Patient Treatment Satisfaction was assessed using a patient-reported satisfaction scale at the specified follow-up assessment. The score reflects the participant's overall satisfaction with the assigned treatment. Higher scores indicate greater treatment satisfaction and a more favorable patient-reported outcome. The minimum and maximum possible scores depend on the scale used.

Vitamin B Complex as a Therapeutic Adjunct for Moderate-to-Severe Dry Eye Disease in Otherwise Healthy Subjects: A Randomized Controlled Trial